Effect of a High Protein Diet on the 24-hour Profile of Ghrelin, GH (Growth Hormone) and IGF-1 (Insulin-like Growth Factor-1)

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: LoBag Diet - test phase; Other: LoBAG Diet - control phase

• Registration Number: NCT00108225
• Lead Sponsor: US Department of Veterans Affairs

Brief Summary

In this study we tested the hypothesis that an increase in protein content of the diet will result in an increase in the 24-hour integrated circulating growth hormone (GH) and insulin-like growth factor-1 (IGF-1) concentrations and an increase in lean body mass in people with untreated type 2 diabetes.

Detailed Description

Subjects with untreated type 2 diabetes were studied using a randomized crossover design. The study began with an initial two-week observation period. Subjects then were randomly assigned to one arm of the study for 5 weeks. The carbohydrate:protein:fat ratio for the control diet is 55:15:30 whereas for the test diet it is 40:30:30. Following a five-week washout period, subjects were assigned to the other arm of the study. All meals were provided by the SDTU. A six-day rotating meal plan has been devised. At the beginning and end of the 5-week diet period, the subject was admitted to the SDTU (Special Diagnostic and Treatment Unit), was provided with the meals appropriate for the test or control arm of the study, and had blood drawn at various times during a 24-hour period. In addition to measurement of GH and IGF-1, IGF-binding proteins 1 and 3, ghrelin, and body composition were determined.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-04-14
• Study First Submitted QC: 2005-04-14
• Study First Posted: 2005-04-15
• Primary Completion: 2008-12
• Study Completion: 2009-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-30
• Last Update Posted: 2014-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• People ages 55 - 75 years old with type 2 diabetes, not receiving oral hypoglycemic agents or insulin.
• Fasting plasma glucose < 250 mg/dl (<14 mM) (tGHb < 14%).

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Exclusion Criteria

• Subjects will be screened for hematological abnormalities, liver disease, kidney disease, macroalbuminuria (>300 mg/24 hours), untreated thyroid disease, congestive heart failure, angina, life-threatening malignancies, proliferative retinopathy, diabetic neuropathy, peripheral vascular disease, serious psychological disorders, a body mass index > 35, and a fasting triglyceride of > 400 mg/dl.
• Presence of any of the above will be considered exclusion criteria.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	LoBag Diet - test phase	30% carbohydrate, 30% protein, 40% fat
Arm 2	LoBAG Diet - control phase	55% carbohydrate, 15% protein, 30% fat

Primary Outcome Measures

Name	Time	Method
IGF-1, GH, Body Composition	5 weeks

Trial Locations

Locations (1)

VA Medical Center, Minneapolis; 🇺🇸 Minneapolis, Minnesota, United States